| CTRI Number |
CTRI/2024/10/074714 [Registered on: 04/10/2024] Trial Registered Prospectively |
| Last Modified On: |
29/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of Indigestion with Unani medicine Jawarish-e-Muqawwi-e-Meda |
|
Scientific Title of Study
|
Clinical Validation of Unani Pharmacopoeial Formulation Jawarish-e-Muqawwi-e- Meda in Duf-al-Mida (Functional Dyspepsia) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DM/JMM/CLNVAL/CCRUM/22-23, Version 01, 07.06.22 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr N Zaheer Ahmed |
| Designation |
Director General |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 502, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
01128525715 |
| Fax |
|
| Email |
drnzaheer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ghazala Javed |
| Designation |
Assistant Director (Unani) |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 506, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
9811810454 |
| Fax |
|
| Email |
ghazala.javed@gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Kumar |
| Designation |
Research Officer (Pathology) S-IV |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 516, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
8800263300 |
| Fax |
|
| Email |
drpradeepkumar2001@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support : 1 Regional Research Institute of Unani Medicine (RRIUM),Patna 2. Clinical Research Unit (CRU), Burhanpur; Monetary Support : Central Council for Research in Unani Medicine (CCRUM), New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine CCRUM New Delhi |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Yasmin Fatima |
Clinical Research Unit |
Research OPD Room Du’f-al-Mi’da (Functional Dyspepsia), Saeeda Hospital Campus, Ganpati Naka
West Nimar
MADHYA PRADESH |
8827166845
yas.fatima2014@gmail.com |
| Dr Mohd Tariq |
Regional Institute of Unani Medicine (RRIUM) |
Research OPD Room Du’f-al-Mi’da (Functional Dyspepsia), Guzri, Patna City
Patna
BIHAR |
8984112448
drtariqbdk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Clinical Research Unit, Burhanpur |
Approved |
| Regional Research Institute of Unani Medicine (RRIUM), Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K30||Functional dyspepsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Jawarish-e- Muqawwi-e- Meda |
5 gm (semisolid) orally to be taken twice daily with water after meals for 4 weeks |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of any sex in age group between 18-65 years.
2. Symptoms onset should start at least 6 months before diagnosis based on one or more of the following symptoms Rome IV criteria (Unpleasant postprandial fullness, early satiety, epigastric pain, and epigastric burning sensation)
3. Who meets Rome IV criteria for functional dyspepsia
4. In addition to the above, patients having any / all of the following
epigastric bloating
excessive belching,
nausea |
|
| ExclusionCriteria |
| Details |
1. Patients below 18 year and above 65 year of age
2. Patients with systemic illness e.g. Diabetes/Hypertension/Tuberculosis/Anemia.
3. Known case of Gastric peptic ulcer with H. pylori Infection or reflux esophagitis within the past 6 months were excluded
4. Gastro intestinal bleeding e.g. Hematemesis or Melena.
5. Known case of gastrointestinal surgery.
6. Known cases of Intra-abdominal malignancy (e.g. stomach/Pancreas/Liver or Gastricleiomyoma /Leiomyosarcoma/ Malignant Lymphoma) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Therapeutic efficacy of the study drug will be assessed on the basis of Response recorded using 05 score Likert dyspepsia incidence scale. |
At every 14th day of treatment for 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological & biochemical assessment for safety assessment i.e. CBC, LFT, KFT, Urine Routine & microscopic examination. |
At baseline and after 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
04/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is designed as a multi centric open trial in patients with Du’f-al-Mi’da (Functional Dyspepsia). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at every 14th day for four weeks. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 04 weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.
| S. No. | Ingredients | Botanical Names | Quantity | | 1. | Mastagi | Pistacia lentiscus Linn. | 05 g | | 2. | Sumbul-ut-teeb | Valeriana Jatamansi De. | 05 g | | 3. | Qaranful | Syzygium aromaticum (L.) | 05 g | | 4. | Ood | Aquilaria agallocha Roxb. | 10 gm | | 5. | Sazaj Hindi | Cinnamomum Tamala Nees & Eberm. | 10 gm | | 6. | Zarnab | Taxus baccata L. | 10 gm | | 7. | Sad Kufi | Cyperus rotundus Linn. | 10 gm | | 8. | Darchini | Cinnamomum Zeylanicum Blume | 10 gm | | 9. | Dana-e-Heel Khurd | Elettaria cardamomum Maton | 20 gm | | 10. | Zarishk | Berberis aristata DC. | 20 gm | | 11. | Gul-e-Surkh | Rosa Damascena Mill. | 20 gm | | 12. | Gaozaban | Borago Officinalis Linn. | 20 gm | | 13. | Qand Safaid | Sugar | 2 times of all ingredients | |